The National Heart, Lung, and Blood Institute (NHLBI), part of the National
Institutes of Health, has launched the first large-scale, multicenter
study to investigate the effectiveness of body cooling treatment in infants
and children who have had cardiac arrest. The Therapeutic Hypothermia
after Pediatric Cardiac Arrest (THAPCA) trials total more than $21 million
over six years.

Therapeutic hypothermia, or body cooling, has been successfully used
in adults after cardiac arrest and in newborn infants after birth asphyxia,
or lack of oxygen, to improve survival and outcomes, but it has not been
studied in infants or children who have had cardiac arrest.

"Children who have experienced cardiac arrest can suffer long-term
neurological damage or death," said NHLBI Acting Director Susan
B. Shurin, M.D., a board-certified pediatrician. "There are abundant
data demonstrating the benefits of hypothermia in adults with cardiac
arrest, but very limited experience in children. This study begins to
assess the effectiveness of therapeutic hypothermia in children, and
should lead to evidence-based guidelines that will optimize both quality
and rates of survival."

During body cooling treatment, THAPCA participants lie on mattresses
and are covered with blankets. Machines circulate water through the blankets
and mattresses to control the participants' body temperatures. Researchers
do not yet know how body cooling will affect participants, since many
factors can contribute to brain injury after cardiac arrest. However,
they believe body cooling could provide several benefits, including less
inflammation and cell death.

According to a 2008 review of pediatric cardiopulmonary resuscitation
in the journal Pediatrics, about 16,000 children suffer cardiac arrest
each year in the United States. Their hearts stop pumping effectively,
and blood stops flowing to their brains and other vital organs. In many
cases, the outcome is death or long-term disability.

Cardiac arrest in infants and children has many causes, such as strangulation,
drowning, or trauma. It can also be a complication of many medical conditions.

"Our goal is to minimize brain injury in infants and children who
experience cardiac arrest and ultimately improve survival rates," said
co-principal investigator J. Michael Dean, M.D., M.B.A., professor of
pediatrics and chief of the Division of Pediatric Critical Care Medicine
at the University of Utah School of Medicine, Salt Lake City.

The THAPCA centers enroll participants in one of two randomized, controlled
clinical trials. One evaluates participants who suffered cardiac arrest
outside the hospital, while the other evaluates participants who suffered
cardiac arrest in the hospital. Within each trial, there are two active
treatment groups: therapeutic hypothermia (cooling the patient to 89.6-93.2
Fahrenheit) and therapeutic normothermia (maintaining the patient at
96.8-99.5 Fahrenheit). Both trials are trying to reduce fever, which
commonly occurs after cardiac arrest and can lead to more severe outcomes.

"These trials are addressing the question: What is the optimal
temperature for an infant or child after cardiac arrest?" said co-principal
investigator Frank W. Moler, M.D., M.S., a professor in the Department
of Pediatrics and Communicable Diseases at the University of Michigan,
Ann Arbor. He added that in previous studies exploring therapeutic hypothermia,
the comparison or control groups did not receive therapeutic normothermia
to prevent fever.

Blanketrol mattress and blanket used for therapeutic
hypothermia.

Participants in the THAPCA trials must be older than 48 hours and younger
than 18 years and must be enrolled in the study within six hours of suffering
cardiac arrest. Once a parent or guardian provides consent, the participant
is randomly assigned to one of the two treatment groups. The therapeutic
hypothermia group in each trial receives the hypothermia treatment for
two days and then normothermia treatment for three days, which ensures
that the body temperature is kept within a normal temperature range.
The patients in the therapeutic normothermia groups receive normothermia
treatment for all five days.

After the five-day period, the clinical care team will continue to provide
study participants with optimal medical care. Participants will undergo
neurological and behavioral testing a year after the cardiac arrest.

The THAPCA trials involve 34 clinical centers in the United States and
Canada. The C.S. Mott Childrens Hospital at the University of Michigan
serves as the lead clinical center, while the data coordinating center
is based at the University of Utah School of Medicine.

The THAPCA trials are being conducted in partnership with the Collaborative
Pediatric Critical Care Research Network, established in 2004 by the
NIH's Eunice Kennedy Shriver National Institute of Child Health and Human
Development, and the Pediatric Emergency Care Applied Research Network,
established in 2001 by the Health Resources and Services Administrations
Maternal and Child Health Bureau.

The NHLBI plans, conducts, and supports research related to the causes,
prevention, diagnosis, and treatment of heart, blood vessel, lung, and
blood diseases; and sleep disorders. The Institute also administers national
health education campaigns on women and heart disease, healthy weight
for children, and other topics. NHLBI press releases and other materials
are available online at www.nhlbi.nih.gov .

The National Institutes of Health (NIH) — The Nation's Medical
Research Agency — includes 27 Institutes and Centers and is
a component of the U.S. Department of Health and Human Services. It is
the primary federal agency for conducting and supporting basic, clinical
and translational medical research, and it investigates the causes, treatments,
and cures for both common and rare diseases. For more information about
NIH and its programs, visit www.nih.gov .